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Adjuvant Aspirin Treatment for Colon Cancer Patients

NCT02467582 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1040

Last updated 2025-05-16

Study results available
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Summary

Following complete resection of their primary tumor, potentially eligible stage II or stage III colon cancer patients will undergo central PIK3CA testing. Patients with somatic mutations will be 2:1 randomized to daily aspirin 100 mg versus placebo for a a maximum of 3 years or until disease recurrence, patient death or withdrawal of consent, whichever occurs first. Patients will be followed up for at least 3 years from the date of surgery.

The intake of aspirin or placebo is independent of adjuvant chemotherapy, and does not impact on the indication to give (or not to give) adjuvant chemotherapy.

Conditions

Interventions

DRUG

Aspirin

Aspirin 100 mg daily

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • Central European Society for Anticancer Drug Research

    collaborator OTHER

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Ulrich Güller, Prof · Spital STS AG Thun

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-09
Primary Completion
2023-09-14
Completion
2023-09-14

Countries

  • Belgium
  • Germany
  • Hungary
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02467582 on ClinicalTrials.gov